Status:
TERMINATED
Prospective Study on Artelon® Tissue Reinforcement in Repair of Chronic Ruptures and Re-ruptures of the Achilles Tendon
Lead Sponsor:
Orthopedic Foot and Ankle Center, Ohio
Collaborating Sponsors:
Artimplant AB
Conditions:
Achilles Tendon Rupture
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to evaluate the surgical and clinical outcome of Artelon® Tissue Reinforcement in repair of chronic ruptures or re-ruptures of the Achilles tendon, with regard to lower leg an...
Eligibility Criteria
Inclusion
- The patient has a clinically confirmed isolated chronic rupture or rerupture of the Achilles tendon.
- The patient has been informed about the study and signed the patient consent form.
- The patient reads, understands and is able to complete the study questionnaires in English.
Exclusion
- The patient has an ongoing infection of the soft tissues of the ankle.
- The patient has evidence of severe ankle arthritis.
- The patient has a multi-system or multi-limb trauma.
- The patient has a major medical condition that would affect quality of life and influence the results of the study.
- The patient is pregnant
- The patient is not expected to complete the study according to the investigation plan.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01237613
Start Date
November 1 2010
End Date
February 1 2014
Last Update
July 22 2015
Active Locations (1)
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1
Orthopedic Foot and Ankle Center
Westerville, Ohio, United States, 43082